US20170050023A1

US20170050023A1 - External and implantable coils for auditory prostheses

Info

Publication number: US20170050023A1
Application number: US15/243,717
Authority: US
Inventors: Martin Evert Gustaf Hillbratt; Werner Meskens; Koen Erik Van den Heuvel
Original assignee: Cochlear Ltd
Current assignee: Cochlear Ltd
Priority date: 2015-08-21
Filing date: 2016-08-22
Publication date: 2017-02-23
Also published as: US11344736B2; US11826576B2; US20220331597A1; US10744333B2; US12138467B2; US20200398060A1; US20240091543A1

Abstract

Certain medical devices, such as auditory prostheses, have an implantable portion and an external portion. The implantable portion and external portion each include a transmission/receiver coil that communicates signals between the two portions. The implanted coil is implanted about the ear canal while the external coil is disposed about the pinna or in the ear canal itself. The proximity of the two coils allows for signal transmission between the implantable and external portions.

Description

BACKGROUND

Hearing loss, which can be due to many different causes, is generally of two types: conductive and sensorineural. Sensorineural hearing loss is due to the absence or destruction of the hair cells in the cochlea that transduce sound signals into nerve impulses. Various hearing prostheses are commercially available to provide individuals suffering from sensorineural hearing loss with the ability to perceive sound. For example, cochlear implants use an electrode array implanted in the cochlea of a recipient (i.e., the inner ear of the recipient) to bypass the mechanisms of the middle and outer ear. More specifically, an electrical stimulus is provided via the electrode array to the auditory nerve, thereby causing a hearing percept.
Conductive hearing loss occurs when the normal mechanical pathways that provide sound to hair cells in the cochlea are impeded, for example, by damage to the ossicular chain or the ear canal. Individuals suffering from conductive hearing loss can retain some form of residual hearing because some or all of the hair cells in the cochlea function normally.
Individuals suffering from conductive hearing loss often receive a conventional hearing aid. Such hearing aids rely on principles of air conduction to transmit acoustic signals to the cochlea. In particular, a hearing aid typically uses an arrangement positioned in the recipient's ear canal or on the outer ear to amplify a sound received by the outer ear of the recipient. This amplified sound reaches the cochlea causing motion of the perilymph and stimulation of the auditory nerve.
In contrast to conventional hearing aids, which rely primarily on the principles of air conduction, certain types of hearing prostheses commonly referred to as bone conduction devices, convert a received sound into vibrations. The vibrations are transferred through the skull to the cochlea causing motion of the perilymph and stimulation of the auditory nerve, which results in the perception of the received sound. Bone conduction devices are suitable to treat a variety of types of hearing loss and can be suitable for individuals who cannot derive sufficient benefit from conventional hearing aids.

SUMMARY

Aspects disclosed herein relate to medical devices having an implantable portion and an external portion. The implantable portion and external portion each include a transmission/receiver coil that are used for signal (data and/or power) transmission between the two portions. The implanted coil is disposed about or around the ear canal while the external coil is disposed about the pinna or in the ear canal itself. The proximity of the two coils allows for signal transmission. In certain examples, configuration and location of the implantable and external coils can result in the elimination of magnets in the implantable and external portions.
This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

The same number represents the same element or same type of element in all drawings.

FIG. 1 is a partial view of an auditory prosthesis worn on a recipient.

FIGS. 2A and 2B are schematic top views of an implantable portion of an auditory prosthesis in accordance with an example of the proposed technology.

FIGS. 2C and 2D depict partial schematic views of a wire bundling system in accordance with an example of the proposed technology.

FIG. 3 is a schematic top view of an implantable portion of an auditory prosthesis in accordance with another example of the proposed technology.

FIGS. 4A and 4B are schematic top and section views of an implantable portion of an auditory prosthesis in accordance with another example of the proposed technology.

FIG. 4C depicts a partial enlarged schematic top view of the implantable portion of FIGS. 4A and 4B.

FIGS. 5A-5C are schematic side views of external portions of auditory prostheses in accordance with examples of the proposed technology.

FIGS. 6A-6C depict examples of external portions of auditory prostheses worn by a recipient.

FIGS. 7A-7C depict examples of auditory prostheses worn by a recipient.

FIG. 8 depicts a method of implanting an implantable portion of an auditory prosthesis.

DETAILED DESCRIPTION

The coil technologies disclosed herein can be used in conjunction with various types of auditory prostheses, including direct acoustic devices and cochlear implants. Such devices include an implantable portion and an external portion. The implantable portion includes an implantable coil disposed around or about the ear canal and provides a stimulus to the recipient. The external portion receives sound, processes sound signals, and sends signals to the implantable coil via an external coil. The external portions can be worn hung from the ear as a so-called behind-the-ear (“BTE”) device, or in the ear canal as a so-called in-the-ear (“ITE”) device (like a traditional acoustic hearing aid). Devices that include a vibrating stimulator or a loud speaker are also contemplated, as are hybrid devices that include a number of different stimulation systems. The corresponding stimulus can be in the form of electrical signals or mechanical actuations. For clarity, however, the technologies disclosed herein will be generally described in the context of cochlear implants.
Referring to FIG. 1, cochlear implant system 10 includes an implantable component 44 typically having an internal or implantable receiver/transceiver unit 32, a stimulator unit 20, and an elongate lead 18. The internal receiver/transceiver unit 32 permits the cochlear implant system 10 to receive signals from (and/or transmit signals to) an external device 100. The internal receiver/transceiver unit 32 includes an internal or implantable coil 36, and a magnet (not shown) fixed relative to the internal coil 36. The received signals generally correspond to external sound 13. Internal receiver unit 32 and stimulator unit 20 are hermetically sealed within a biocompatible housing, sometimes collectively referred to as a stimulator/receiver unit. The magnets facilitate the operational alignment of the external and internal coils, enabling internal coil 36 to receive power and stimulation data from external coil 30. The external coil 30 is contained within an external portion attached to a head of a recipient. Elongate lead 18 has a proximal end connected to stimulator unit 20, and a distal end implanted in cochlea 40. Elongate lead 18 extends from stimulator unit 20 to cochlea 40 through mastoid bone 19.
In certain examples, external coil 30 transfers electrical signals (e.g., power and stimulation data) to internal coil 36 via a radio frequency (RF) link, as noted above over a closely coupled inductive coil link. Internal coil 36 is typically a wire coil comprised of multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire. The electrical insulation of internal coil 36 is provided by a flexible silicone molding. Various types of energy transfer, such as electromagnetic, capacitive and inductive transfer, can be used to transfer the power and/or data from external device to cochlear implant. Several configurations of external and internal coils are described in further detail herein.
There are a variety of types of intra-cochlear stimulating assemblies including short, straight and peri-modiolar. Stimulating assembly 46 is configured to adopt a curved configuration during and or after implantation into the recipient's cochlea 40. To achieve this, in certain arrangements, stimulating assembly 46 is pre-curved to the same general curvature of a cochlea 40. Such examples of stimulating assembly 46, are typically held straight by, for example, a stiffening stylet (not shown) or sheath which is removed during implantation, or alternatively varying material combinations or the use of shape memory materials, so that the stimulating assembly can adopt its curved configuration when in the cochlea 40. Other methods of implantation, as well as other stimulating assemblies which adopt a curved configuration, can be used.
Stimulating assembly can be a peri-modiolar, a straight, or a mid-scala assembly. Alternatively, the stimulating assembly can be a short electrode implanted into at least in basal region. The stimulating assembly can extend towards apical end of cochlea, referred to as cochlea apex. In certain circumstances, the stimulating assembly can be inserted into cochlea via a cochleostomy. In other circumstances, a cochleostomy can be formed through round window, oval window, the promontory, or through an apical turn of cochlea.
Speech processing components, such as microphones, speech processing hardware and software, and other elements, can be disposed within a housing separate from the implantable portion of the auditory prosthesis. In certain examples, such components can be contained in an external portion that also includes the external coil described above. In another example, the sound processing components can be contained within a BTE device, such as BTE 100 depicted in FIG. 1. In the latter case, signals from the sound processing components are sent to an external portion containing the external coil.
FIGS. 2A and 2B are schematic top views of an implantable portion 200 of an auditory prosthesis in accordance with an example of the proposed technology, and are described simultaneously. The implantable portion 200 includes a housing 202 typically of silicone or other biocompatible material. A stimulator unit 204 is disposed therein and generates a stimulus (e.g., an electrical signal) to be delivered to the cochlea. The stimulator unit 204 is connected to one or more transmission elements such as electrodes 206 a, 206 b that extend therefrom. The electrodes 206 a, 206 b are utilized to transmit or conduct the electrical stimulus signals to the cochlea. As described above, cochlear implants also typically include a coil and a magnet disposed in the housing 202. In the depicted example, however, a flexible wire 208 that functions as the coil is disposed outside the housing 202. In an example, the wire 208 can be gold doped in calcium. Moreover, in certain examples, a magnet need not be utilized. In a significant deviation from known systems, the flexible wire 208 is connected at a first end 210 to the stimulator unit 204. As part of the implantation procedure, the implantable portion 204 is implanted proximate the ear canal, as known to persons of skill in the art. The flexible wire 208 is routed about the ear canal C to form one or more loops 212 that, once the loops 212 are completed, form a receiver coil 214. To ease implantation and guiding of the wire 208, a second end 216 can include a needle 218, which a surgeon can use to guide the wire 208 around the ear canal C using forceps or other instruments. Once the desired number of loops 212 are made about the ear canal C, the needle 218 acts as a connector and is connectable to a port 220 in the stimulator unit 204 and the housing 202. Once detachably received in the port 220, the completed implantable coil 214 is formed. Any number of loops 212 can be made about the ear canal C, as required or desired for a particular application. In certain examples, a greater number of loops 212 can be utilized to form a coil 214 having greater quality of signal transmission/reception.
The examples depicted in FIGS. 2A and 2B depict loose loops 212 of the wire 208 that form the coil 214. However, it can be advantageous that the loops 212 are disposed close to each other so as to improve signal transmission and reception. In that regard, FIGS. 2C and 2D depict a wire bundling system 250 in accordance with an example of the proposed technology and are described simultaneously. A wire 208 is surrounded by a silicone or other resilient, flexible sheath or sleeve 252 that electrically insulates. Additionally, the sleeve 252 can be stretchable and the wire 208 can have a wave-like configuration so as to lengthen as the sleeve 252 is stretched. The sleeve 252 includes a body 254 in which the wire 208 is disposed. Secured to or integral with the body 254 is a U-shaped bracket 256. The U-shaped bracket 256 defines a channel 258 sized to receive the body 254 as it is looped during implantation. During implantation, a first loop about the ear canal C is made as described above. Thereafter, an end of the body 254 is inserted into the U-shaped bracket 256 and advanced substantially parallel within an axis A of the channel 258 until a bundle 260 having the desired number of closely-disposed loops is formed. An interior surface of the U-shaped bracket 256 can be coated with a low-friction coating to ease sliding insertion of the body 254 therein.
FIG. 3 is a schematic top view of an implantable portion 300 of an auditory prosthesis in accordance with another example of the proposed technology. A number of the elements are described above with regard to FIGS. 2A and 2B and are not necessarily described further. These elements are numbered consistently with those of FIGS. 2A and 2B, but beginning with 300. Here, the wire 308 is configured in a helical shape, which can provide greater flexibility during implantation of the wire 308, and can also improve signal transmission/reception quality. As with the examples depicted elsewhere herein, one or more loops 312 about the ear canal C can be made.
FIGS. 4A and 4B are schematic top and section views of an implantable portion 400 of an auditory prosthesis in accordance with another example of the proposed technology. FIGS. 4A and 4B are described simultaneously along with FIG. 4C, which depicts a partial enlarged top view of the implantable portion 400. A number of the elements are described above with regard to FIGS. 2A and 2B and are not necessarily described further. These elements are numbered consistently with those of FIGS. 2A and 2B, but beginning with 400. A first end 410 of a wire 408 is connected to and extends from a stimulator unit 404 and makes a number of turns or partial loops 412 in a generally circular pattern before terminating at a second end 416. This circular pattern of curved wire 408 forms a substantially circular coil 414. At the second end 416, the wire 408 terminates at a connector 418 a. The loops 412 can optionally be disposed within a flexible sleeve 418 which can be manufactured from the same material as the housing 402 (e.g., silicone) and in certain examples is integral therewith. The sleeve 418 can be biased into a predefined orientation (e.g., curved) so it can more easily encircle the ear canal C during implantation. A biasing element 422 can include a wire or elastic element within or on the sleeve 418 that urges the sleeve 418 into a predefined configuration. Once disposed completely around the ear canal C, the connector 418 a can be inserted into a mating port 420 in the housing 402 and connected to stimulator unit 404. A seal can be formed between the sleeve 418 and the port 420, e.g., with a friction fit, snap connector, adhesive, or combinations thereof. Once connected, the sleeve 418 forms an annulus with an open central portion. In another example, the wire 408 and sleeve 418 can be permanently connected at the stimulator unit 404.
As described above, certain examples of implantable portions depicted herein do not utilize a magnet. This has significant advantages in that the implantable portion can still be worn by the recipient during a magnetic resonance imaging (MM) or other procedure that would typically require removal of the implantable portion and/or magnet. Typically, magnets in the implantable portion and in the external portion of the auditory prosthesis interact so as to hold the external portion proximate the implantable portion to ensure proper signal transmission between the implantable coil and external coil. Absence of magnets, therefore, can cause signal transmission problems between the implantable portion and the external portion. The disclosed technologies address this and other problems by disposing the external transmission coil proximate the area of implantation of the implantable coil, and utilize body parts (e.g., the pinna or the ear canal) to ensure the implantable and external coils remain proximate each other when the external portion is disposed in or proximate the head.
FIGS. 5A-5C are schematic side views of external portions 500 a-500 c of auditory prostheses in accordance with examples of the proposed technology. In FIG. 5A, the auditory prosthesis 500 a includes a housing 502 a, in this case in the form factor of a BTE device. The BTE device 500 a includes a sound processor, microphones, batteries, and other components described herein, which are not depicted in FIG. 5A. The BTE device 500 a includes a wire or lead 504 a extending therefrom. In the depicted example, the wire 504 a is a twisted radio frequency (RF) coil that adapts to the circumference of the pinna. The wire 504 a can be disposed in a flexible (e.g., silicone) sleeve 506 a for comfort when in contact with the pinna of the recipient. The sleeve 506 a can be substantially transparent or flesh-colored to disguise the appearance thereof. An oval shape can help further disguise the sleeve 506 a. In other examples, circular, crescent, or other shapes can be utilized. The wire 504 a can be configured to straighten within the silicone sleeve 506 a, so as to more comfortably stretch to fit the recipient, regardless of pinna size. A portion 508 a of the wire 504 a is disposed within the housing 502 a, to form a complete coil 510 a. In FIG. 5B, an auditory prosthesis 500 b includes a housing 502 b and a wire 504 b having at least a portion 508 b disposed therein. The wire 504 b includes a connector 512 b that connects a second end 514 b of the wire 504 b to the housing 502 b, so as to form a complete coil 510 b. As above, the wire 504 b can be disposed within a silicon sleeve 506 a, if required or desired. In this example, after the BTE device 500 b is placed on the pinna, the wire 504 b and sleeve 506 b can be looped around the pinna and connected to the housing 502 b with a connector 512 b, thus forming the coil 510 b. In FIG. 5C, an auditory prosthesis 500 c includes a housing 502 c and a wire 504 c having at least a portion 508 c disposed therein. The wire 504 c includes an elastic ring 516 c that can be used to tighten the coil 510 c around the pinna. As above, the wire 504 c can be disposed within a silicon sleeve 506 c.
FIGS. 6A-6C depict examples of external portions 600 a-600 c of auditory prostheses worn by a recipient. In FIG. 6A, the auditory prosthesis includes an external portion having a housing 602 a worn behind the ear (as a BTE device) and a coil 604 a disposed about the pinna. In FIG. 6B, the auditory prosthesis has a housing 602 b configured to fit within the ear canal (as an ITE device). An external coil 604 b is connected to the housing 602 b and extends around the pinna. In FIG. 6C, the housing 602 c of the auditory prosthesis 600 c is configured to fit within the ear canal (again, as in an ITE device). The housing 602 c contains an external coil 604 c that communicates with an implantable coil 606 c disposed about the ear canal, as described elsewhere herein. The implantable coil 606 c is connected to a stimulator unit 608 c, such as those depicted above.
FIGS. 7A-7C depict examples of auditory prostheses 700 a-700 c worn by a recipient. The relative positions of the various components and the ear canal C are depicted and described in more detail herein. In FIG. 7A, the auditory prosthesis 700 a includes an external portion 702 a in the form of a BTE device housing 704 a. A coil 706 a sized to encircle the pinna is connected to the BTE device housing 704 a, for example in one of the configurations depicted herein. An implantable portion 708 a is a cochlear implant having a housing 710 a containing a stimulator unit. A coil 712 a is disposed about the ear canal C. Given the proximity of the coils 706 a, 712 a, signals can be communicated therebetween so as to cause a stimulus to be sent to a recipient of the auditory prosthesis 700 a.
In FIG. 7B, the auditory prosthesis 700 b includes an external portion 702 b in the form of a BTE device housing 704 b. Here, the BTE device housing 704 b is configured so as to be worn low on the pinna. This can be desirable because it allows the BTE device housing 704 b to be at least partially hidden by the ear lobe. Additionally, one or more microphones 714 b can be disposed on a forward-facing surface of the BTE device housing 704 b, which can improve sound reception. A coil 706 b sized to encircle the pinna is connected to the BTE device housing 704 b, for example in one of the configurations depicted herein. An implantable portion 708 b is a cochlear implant having a housing 710 b containing a stimulator unit. A coil 712 b is disposed about the ear canal C. Given the proximity of the coils 706 b, 712 b, signals can be communicated therebetween so as to cause a stimulus to be sent to a recipient of the auditory prosthesis 700 b.
In FIG. 7C, the auditory prosthesis 700 c includes an external portion 702 c in the form of a ITE device housing 704 c. Here, the ITE device housing 704 c is configured so as to be disposed within the ear canal (not shown here). A coil 706 c is disposed within the ITE device housing 704 c, thus providing a very non-obtrusive option for recipient who may desire the discretion of a more traditional hearing aid. An implantable portion 708 c is a cochlear implant having a housing 710 c containing a stimulator unit. A coil 712 c is disposed about the ear canal. Given the proximity of the coils 706 c, 712 c, signals can be communicated therebetween so as to cause a stimulus to be sent to a recipient of the auditory prosthesis 700 c.
FIG. 8 depicts a method 800 of implanting an implantable portion of an auditory prosthesis. The method 800 begins at operation 802 where an incision is formed in the head of a recipient, proximate the pinna. At operation 804, an implantable portion of an auditory prosthesis is inserted into the incision. As described elsewhere herein, the implantable portion can be a cochlear implant, direct acoustic stimulator, or other implantable portion of an auditory prosthesis. At operation 806, a wire is implanted about the ear canal so as to form a coil. Operation 808 describes an example implantation of the wire which can include guiding an end of the wire about the ear canal. In decision 810, it is determined if a desired number of loops are formed. If the desired number of loops are not formed, flow returns to operation 808. If the desired number of loops have been formed, flow continues to operation 812. Of course, certain examples of implantable devices described herein require only a single loop about the ear canal (e.g., the sleeve and wire combination of FIGS. 4A and 4B). Once the desired number of loops are formed, operation 812 describes connecting the end of the wire to the implantable portion. The incision can then be closed. Other coil implantation processes are contemplated. For example, the ear canal can be severed or the pinna can be at least partially removed so as to ease implantation. In such an example, an implantable portion similar to the type depicted in FIGS. 4A-4C can be utilized. Such an example would have a wire 408 and a sleeve 418 permanently connected at both ends thereof to the stimulator unit 404. Once the ear canal and/or pinna have been severed, or partially removed, the annular sleeve 418 can be placed around the ear canal, and then the severed/removed anatomy can be reattached.
This disclosure described some examples of the present technology with reference to the accompanying drawings, in which only some of the possible examples were shown. Other aspects can, however, be embodied in many different forms and should not be construed as limited to the examples set forth herein. Rather, these examples were provided so that this disclosure was thorough and complete and fully conveyed the scope of the possible examples to those skilled in the art.
Although specific aspects are described herein, the scope of the technology is not limited to those specific examples. One skilled in the art will recognize other examples or improvements that are within the scope of the present technology. Therefore, the specific structure, acts, or media are disclosed only as illustrative examples. The scope of the technology is defined by the following claims and any equivalents therein.

Claims

What is claimed is:

1. A system comprising:

an implantable portion including:

a housing;

a stimulator unit disposed within the housing for generating an stimulus;

a flexible sleeve connected to the housing; and

a wire disposed within the sleeve, wherein the wire comprises a connector disposed at an end of the wire; and

at least one transmission element extending from the implantable portion for transmitting the stimulus.

2. The system of claim 1, wherein the stimulator unit comprises a port for detachably receiving the connector, and wherein when the connector is received in the port, the sleeve defines an annulus.

3. The system of claim 1, further comprising:

an external portion including:

an external housing disposed remote from the implantable housing; and

an external coil configured to communicate with the implantable coil

when disposed proximate a head of a recipient.

4. The system of claim 3, wherein the external housing comprises a behind-the-ear portion of an auditory prosthesis, and wherein the external coil is sized to be disposed about a pinna of the recipient.

5. The system of claim 3, wherein the external housing comprises an in-the-ear portion of an auditory prosthesis, and wherein the external coil is sized to be disposed about a pinna of the recipient.

6. The system of claim 3, wherein the external housing comprises an in-the-ear portion of an auditory prosthesis, and wherein the external coil is disposed within the in-the-ear portion.

7. The system of claim 1, wherein the connector comprises a needle for connecting at least a portion of the wire to the external housing.

8. The system of claim 1, wherein the sleeve is biased into a curved configuration.

9. An apparatus comprising:

an implantable housing including a stimulator unit disposed within the implantable housing for generating an stimulus;

an flexible implantable wire extending from the implantable housing and in communication with the stimulator unit, wherein the flexible implantable wire includes a first end connected to the stimulator unit and a second end connectable to the stimulator unit, wherein the flexible implantable wire is configured to send a signal to the stimulator unit; and

at least one transmission element extending from the implantable housing for transmitting the stimulus generated by the stimulator unit.

10. The apparatus of claim 9, wherein the flexible implantable wire has a substantially helical shape.

11. The apparatus of claim 9, wherein the flexible implantable wire is embedded in a biocompatible material.

12. The apparatus of claim 11, wherein the biocompatible material is substantially identical to a material that forms the implantable housing.

13. The apparatus of claim 9, wherein implantable housing comprises a port for receiving the second end.

14. The apparatus of claim 9, wherein the apparatus is a cochlear implant and is characterized by an absence of a retention magnet.

15. The apparatus of claim 9, wherein the second end is a needle.

16. A system comprising:

an external portion of an auditory prosthesis, the external portion including:

a sound processor; and

an external coil configured to receive a signal from a sound processor; and

an implantable portion of the auditory prosthesis, the implantable portion including:

a stimulator unit disposed within the implantable portion for generating an electrical signal;

a flexible implantable wire extending from the implantable portion and in communication with the stimulator unit, wherein the flexible implantable wire includes a first end connected to the implantable portion and a second end connectable to the implantable portion; and

at least one electrode extending from the implantable portion and for transmitting the electrical signal generated by the stimulator unit.

17. The system of claim 16, wherein both the sound processor and the external coil are disposed within the external portion.

18. The system of claim 16, wherein the sound processor is disposed within the external portion and the external coil is connected at a first end to the external portion and connectable at a second end to the external portion.

19. The system of claim 18, wherein the external portion comprises a behind-the-ear portion of the auditory prosthesis.

20. The system of claim 17, wherein the external portion comprises an in-the-ear portion of the auditory prosthesis.